Clinical Trials /

Phase I Trial of BAY1251152 for Advanced Blood Cancers

NCT02745743

Description:

The purpose of this study is to identify the most appropriate dose that can be safely administered and that can have an effect on blood cancer cells. Once that safe dose is identified, additional patients will be asked to join the study to further evaluate the safety and effectiveness of the study drug. The study will also investigate the pharmacokinetics (study of what the body does to the drug), as well as pharmacodynamics (study of what the drug does to the body), which may provide information about the effects of BAY 1251152. The study will also measure some biological markers (markers of biological activity in your body) that can be used to predict the response and safety of the proposed treatment.

Related Conditions:
  • Hematopoietic and Lymphoid Malignancy
Recruiting Status:

Completed

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Phase I Trial of BAY1251152 for Advanced Blood Cancers
  • Official Title: An Open-label, Multicenter Phase I Study to Characterize the Safety, Tolerability, Preliminary Anti-tumor Activity, Pharmacokinetics and Maximum Tolerated Dose of BAY1251152 in Patients With Advanced Hematological Malignancies

Clinical Trial IDs

  • ORG STUDY ID: 18117
  • SECONDARY ID: 2015-005122-18
  • NCT ID: NCT02745743

Conditions

  • Hematologic Neoplasms

Interventions

DrugSynonymsArms
BAY1251152Arm 1

Purpose

The purpose of this study is to identify the most appropriate dose that can be safely administered and that can have an effect on blood cancer cells. Once that safe dose is identified, additional patients will be asked to join the study to further evaluate the safety and effectiveness of the study drug. The study will also investigate the pharmacokinetics (study of what the body does to the drug), as well as pharmacodynamics (study of what the drug does to the body), which may provide information about the effects of BAY 1251152. The study will also measure some biological markers (markers of biological activity in your body) that can be used to predict the response and safety of the proposed treatment.

Trial Arms

NameTypeDescriptionInterventions
Arm 1ExperimentalBiomarker-enriched advanced hematological neoplasms
  • BAY1251152
Arm 2ExperimentalOther selected advanced hematological neoplasms
  • BAY1251152

Eligibility Criteria

        Inclusion Criteria:

          -  Male or female patients aged ≥18 years

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 and Life
             expectancy of at least 12 weeks

          -  Patients are able and willing to provide bone marrow biopsies/aspirates as requested
             by the protocol

          -  Patients with confirmed advanced hematological malignancies

          -  Negative serum pregnancy test

          -  Women and men of reproductive potential must agree to use highly effective
             contraception when sexually active.

          -  Ability to understand and the willingness to sign a written informed consent.

          -  Patients must have adequate coagulation (international normalized ratio (INR) or
             prothrombin time (PT), partial thromboplastin time (PTT) ≤1.5 times ULN)

          -  Adequate liver function (total bilirubin ≤ 1.5 times the ULN, alanine aminotransferase
             (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times ULN

        Exclusion Criteria:

          -  Presence of active/uncontrolled central nervous system involvement

          -  History of clinically significant cardiac disease; uncontrolled hypertension

          -  Left ventricular ejection fraction (LVEF) < 45%

          -  Allogeneic stem cell transplant within 100 days before first dose of study drug

          -  Known history of human immunodeficiency virus (HIV) infection

          -  Chronic or active hepatitis B or C, requiring antiviral therapy

          -  Evidence of history of bleeding disorder, dialysis, or coexisting cancer that is
             distinct in primary site or histology from the cancer evaluated in this study

          -  Serious, uncontrolled infection

          -  Unresolved chronic toxicity > grade 1 from prior therapy

          -  Use of strong CYP3A4 inhibitors or strong inducers within 7 days prior to the start of
             study treatment and for the duration of the study
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Maximum tolerated dose(MTD)
Time Frame:21 days
Safety Issue:
Description:To determine the MTD of BAY1251152 in subjects with advanced hematological neoplasms

Secondary Outcome Measures

Measure:Response assessment of BAY 1251152 in hematological malignancies based on the internationally accepted criteria for the specific hematological malignancy which patient is suffering from
Time Frame:Up to 30 months
Safety Issue:
Description:To assess the clinical efficacy of BAY 1251152 in subjects with advanced hematological neoplasms

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Bayer

Trial Keywords

  • Phase 1
  • Dose escalation
  • Dose expansion
  • Positive transcription elongation factor b inhibitor
  • Cyclin-dependent kinase 9 inhibitor

Last Updated

August 18, 2017